Trial Outcomes & Findings for Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (NCT NCT01234766)

Results Overview

The primary endpoint is complete response (CR) rate. Historical complete response (CR) rate has been 35%. This rate will be considered as the null hypothesis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

3 years

Results posted on

2021-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=39 Participants Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=39 Participants
Age, Categorical >=65 years	11 Participants n=39 Participants
Sex: Female, Male Female	22 Participants n=39 Participants
Sex: Female, Male Male	17 Participants n=39 Participants
Region of Enrollment United States	39 Participants n=39 Participants

PRIMARY outcome

Timeframe: 3 years

The primary endpoint is complete response (CR) rate. Historical complete response (CR) rate has been 35%. This rate will be considered as the null hypothesis.

Outcome measures

Outcome measures
Measure	Single Arm n=35 Participants Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Number of Participants With Complete Response at 3 Years	30 Participants

Adverse Events

Single Arm

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=39 participants at risk Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Infections and infestations Basilar pneumonia	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of treatment until 30 days after the last dose of treatment, approximately 7 months.
Infections and infestations Herpes zoster	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of treatment until 30 days after the last dose of treatment, approximately 7 months.
General disorders Infusion related reaction	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of treatment until 30 days after the last dose of treatment, approximately 7 months.
Nervous system disorders JC Virus/Progressive Multifocal Leukoencephalopathy	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of treatment until 30 days after the last dose of treatment, approximately 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary malignancy	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of treatment until 30 days after the last dose of treatment, approximately 7 months.

Other adverse events

Adverse event data not reported

Additional Information

Frederick Lansigan, MD

Dartmouth-Hitchcock Medical Center

Phone: 603-650-4628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place